Jobs (Biotech & Pharmaceuticals)

GlaxoSmithKline
20Aug
Director, Communications & Government Affairs, Pharma Classic & Established Brands
GlaxoSmithKline

Your Responsibilities:


Job Purpose:


GSK creates value for patients, society and shareholders by bringing medicines and vaccines to the people that will benefit from them all over the world.


To support this the Director, Pharma R&D, Product and Pipeline Communication and Government Affairs will be responsible    Read more

for planning, development and delivery of strategic communications to support GSK’s Classic and Established Products (CEP) business. This will include product-specific or disease area programmes, which enhance understanding and build trust with key stakeholders, and protect the reputation of GSK, as well as providing external and internal communications support for our Classic and Established Products business, including support for the CEP Leadership Team based out of Singapore.


This is an opportunity to build a global communications career in a team that will develop, support and stretch you, in a company whose business values will make you proud.



Key Responsibilities:


Delivery of our three strategic priorities in Pharma: Innovation, Performance and Trust (IPT) through development and implementation of CGA plans aligned to the overall business strategy, by:


Providing senior level communications counsel and strategic advice to the Classic and Established Products Leadership Team


Ensure understanding of the business, disease areas, assets, and brand strategies and operational plans to allow effective development and delivery of aligned communications campaigns, content and briefing materials that support the business priorities, particularly through social/digital channels


Provide internal communications strategic counsel and support, particularly in the area of business strategy, employee engagement and raising awareness of the strategic role and significance of the CEP business within GSK


Establish the SVP, CEP as a thought-leader in the pharmaceutical industry, identifying relevant topics, developing thought leadership pieces and amplifying these in relevant media and social channels, with a focus on LinkedIn, that help support the business and/ or drive engagement


Proactively identify and engage with relevant media as needed


Anticipating and preparing for products /therapy area issues to enable rapid and appropriate response. Leading the development of communications materials for Corporate and LOC communicators


Ensure ongoing engagement with communicators across the network to ensure consistent and successful implementation of comms plans, and support localisation where relevant


Represent the needs / opinions of the CEP business within Global Communications


Give counsel to investor relations and global corporate communications on relevant GSK and competitor news flow, to maintain market confidence and GSK reputation


Line management of Communications Manager


Ensuring all communications programmes are measurable and compliant with GSK codes of conduct, ethics and values



Core Deliverables and Outputs:



Development of external communications plan – with a focus on social media/digital comms - in alignment with operational/brand plans to amplify marketing efforts, which can be utilized globally and within key markets


Development and delivery of a digital profiling plan to support the continued visibility of SVP, CEP and other senior stakeholders as thought-leaders on key business issues and industry topics via select social channels


Update and maintain the CEP narrative, developing all communications materials and ensuring that the narrative is effectively communicated and adopted through the business and understood within the broader organisation


Update and maintain internal communications channels and materials, including monthly newsletter, email communications template and content, intranet site, Yammer, Facebook Workplace etc.


Plan and coordinate content and logistics for town halls and relevant broadcast events


Trained and competent senior spokespeople available


Responsibility for communications agency involvement in the development and execution of the relevant communications plan and materials


Reputational risk assessment and development and maintenance of issues management plans and materials


Monitor uptake and impact of communications plans to evaluate progress, outcomes and effectiveness of communications and adjust according to metrics


Effective budget management for all communications activities undertaken to support product communications


LI-GSK



Why You?




Basic qualifications:



Basic Requirements:



Strategic, analytical and proactive individual


Strong verbal and written skills, with good commercial acumen and understanding and proven experience in developing thought leadership pieces that are differentiated and which resonate with key external audiences


Experience of working within a media relations environment, with journalists and other third parties including patient organisations, external experts, governmental bodies, understanding and accommodating differing needs and expectations


High personal accountability combined with the ability and experience to influence decision-making at a senior, strategic level


Excellent organisational and project management skills


Sound judgement, high personal and business integrity


Strong and dynamic communicator


Can take a global view and understand regional / local needs


Flexible and self-motivated; able to juggle competing priorities and remain focused in a matrix organisation


Networking skills: development of productive relationships with key stakeholders, internally, cross-functions and disciplines and externally; and across different cultures and countries



Supportive, enthusiastic team player


Preferred qualifications:




Specialist Knowledge


Extensive Pharmaceutical, R&D, corporate, product & / or healthcare communications (in-house or agency) experience


Comprehensive understanding of the risks, challenges and opportunities affecting the external healthcare environment, Pharmaceutical Industry and governance


Extensive experience of developing, implementing and measuring communications strategies and tactics that support commercial objectives


Strong business partnering skills; capable of influencing and inspiring key stakeholders, to contribute to the development of and successful implementation of communication strategies and plans


Deep understanding of online and offline media


Strong business acumen and understanding of commercial, matrixed environment


Practical understanding of the regulatory environment and processes


Extensive experience of issues management and strong judgment


Bachelors degree or equivalent and prior Communications experience in large, complex, multi-national organisations is preferred



Why GSK?

:


GlaxoSmithKline (GSK) is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have three global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies.

We are proud of the difference we make. GSK has ranked 1st in the Access to Medicines Index all five times since its launch in 2008 and FORTUNE Magazine ranked us #1 on its ‘Change the World list’ which recognises companies that have made significant progress in sustainable, scalable approaches to addressing societal problems as part of their company strategy.

GSK has been present in Asia for over 50 years and our commitment to the region is strengthened by the establishment of our purpose-built headquarters for Asia. Situated in Singapore, GSK Asia House is a further step in our long-standing strategy to grow and diversify our company - emphasizing the globally balanced business we have built over the years. To better support Asia, we focus on developing talent to improve our ability to make the right decisions for healthcare professionals, patients and consumers across the region.

At GSK Pharmaceuticals, we are changing the face of healthcare. Our Pharmaceutical business has a broad portfolio of innovative and established medicines. We currently focus on developing new medicines in respiratory and HIV/infectious diseases, oncology and immuno-inflammation; with discovery research exploring these and other areas.


What We Can Offer You

GSK’s dedication to the wellbeing of our employees is reflected in the benefits we offer; including healthcare for yourself and dependents, performance related bonus, long term incentives and a host of other flexible offerings you can tailor to your own preferences. We also offer a range of employee health and wellbeing programs including our truly unique Partnership for Prevention program, a global commitment by GSK to provide all employees with up to 40 preventative healthcare services bringing to life our mission to: do more, feel better and live longer.


Application Process

At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

If you would like to join us in innovating and inspiring changes in the industry, we urge you to apply.


Closing date for applications: 03-SEP-2018


Contact information:


You may apply for this position online by selecting the Apply now button.


Important notice to Employment businesses/ Agencies


GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Vela Diagnostics
20Aug
Scientist
Vela Diagnostics

As a Scientist, you will be a major contributor to design and development of new IVD products. You will interact closely with other Vela’s departments (Marketing, Manufacturing, Quality Assurance, Tech. Support, Tech. Transfer, etc.) and external partners such as clinicians. You will contribute to project documentation, including writing work plans, protocols and reports. You will also be expected to help with other administrative tasks such as lab management,    Read more

recruiting, etc.

Duties and responsibilities:-

  • Design and develop innovative products for Next Generation Sequencing- and qPCR- based in vitro Laboratory Diagnostics
  • Generate test protocols to verify and validate assay performance
  • Analyze data; prepare project related technical reports and documents
  • Follow processes that meet FDA QSR and ISO 13485 requirements
  • Work with a team of up to Scientists and Research Officers in Vela’s R&D department in Singapore
  • Work closely with manufacturing and marketing staff
  • Coordinate and support Researchers and Project Managers
  • Support company’s R&D facility setup and expansion with process transfers and qualification of characterization equipment
  • Be instrumental in Patent filing and IP management
  • Prepare publications
  • Establish collaborations, collect VOC, obtain samples and templates from different sources
  • Screen CVs and interview shortlisted candidates for technical positions in R&D department
  • Be ready for international travel
  • Collaborate with all functions within project teams.

Job requirements and Attributes:

  • Candidate must process at least a Bachelor’s Degree, Professional Degree, Master Degree, Doctorate (PhD), in Biochemistry, Microbiology, Genetics, Molecular Biology, Medical or a equivalent.
  • Relevant background in molecular diagnostic assay development
  • Experience in microbiology is a plus.
  • At least 1 year(s) of working experience in the related field is required for this position.
  • Proven direct project and people management skills
  • Good interpersonal skills for interacting with team members
  • Experience in delivering products to a cGMP regulated market, including development through the verification and validation process, premarket testing, transfer of product specifications and regulatory compliance
  • Experience in ISO 13485 regulated environment desired
  • Experience in 510(k) submissions and preferably PMA process for IVD molecular assays desired
  • Preferred experience in use and development of NGS technologies and/or real-time and/or reverse-transcriptase-PCR assays.  Experience with asymmetric PCR systems and melting curve analysis desired
  • Preferred experience in product design and development of nucleic acid-based assays in a regulated environment
  • Training and experience in statistical analysis and Design of Experiment methodology desired
  • In-depth knowledge of molecular biology, including searching and analysis of genetic databases, principles of nucleic acid hybridization, probe and primer design and enzymatic amplification of specific gene sequences
  • Ability to write plans, procedures, reports, etc., to support assay development, product transfer, Verification, and Validation phases
  • Organizational, planning and detailed follow-up skills
  • Ability to work in a team environment, with the ability to relate to both highly educated and less skilled team members.
  • Ability to handle and resolve conflicts and work under stressful conditions
  • Demonstrated ability or track record of successful results
  • Ability to understand scientific, engineering and business concepts
  • Demonstrated ability to be flexible and resourceful.  Strong communication and diplomacy skills
  • Desired knowledge of safety precautions required for working with pathogens at Biosafety Level 1 and 2

Johnson & Johnson
20Aug
Franchise Support Executive
Johnson & Johnson

Provide administrative support to the One J&J Hospital Group, Orthopaedic Team. Provide AO secondment role to AO Foundation. Provide support in Office Administration duties. To undertake any other duties or responsibilities deemed necessary, for the advancement of the Company




REPORTING LINE



This position reports to Franchise Support Manager, Singapore



JOB RESPONSIBILITIES:
   Read more





Provide administrative support to the


One J&J Hospital Group, Orthopaedic Team



Coordinate HCC and A&P expenditure requests, communicate approvals/ reimbursement instructions to commercial team and external 3rd parties


Coordinate IO and Expenditure requests, monitoring and reporting.


Coordinate signatories from internal approvers (Legal, HCC, Commercial Leaders) to formalise agreements with KOLs, including liaison with institutions or society


Prepare, process and file various forms for internal approval


Support other team members and promote a positive team environment, including ad-hoc support to coordinate travel, accommodation and congress registration for KOL and sales staff


Provide end to end support to sales & marketing team in the overall administration function including IO process, eMarketplace & ARAVO, HCC Life submission, pre & post event documentation, file management, travel arrangement and adhoc office supply ordering, PO & RFP


Consolidate and submit monthly activity report (e.g. IO budget expenditure status report, HCC open status report, Calendar of Events)


Work on various projects and tasks as assigned



Congresses and workshop support for


J&J Hospital Group, Orthopaedic Team (Sales & Marketing)



Provide support in meeting/ conferences arrangements and workshop materials


Sourcing and liaising with 3rd party vendor to support workshop requirements.


Onsite support is needed when required


Work on various projects and to undertake any other duties or responsibilities deemed necessary, for the advancement of the Company



AO Secondment support to AO Foundation



Undertake the secondment to AO Foundation to support AO educational events. A 3-year secondment period upon signing of undertaking.


Fulfil and abide to the terms and conditions as set in the secondment undertaking



Qualifications



Diploma in Marketing/ Degree holder or related qualification or relevant working experience


Excellent computer skills and MS Office ( Word, Excel, Powerpoint, Access, Outlook)


Ability to develop and maintain strong business relationship with clients and vendors


High standard of professional presentation with a bright and cheerful disposition


Well organized and detail oriented, yet able to multi task and willing to take on new challenges


Self-motivated, high initiative and excellent communication skills


Flexible with working hours, able to put in extra effort when required



Primary Location


Singapore-Singapore-Singapore


Organization


Johnson & Johnson Pte. Ltd. (8435)


Job Function


Sales Administration


Requisition ID



1805677781W

Johnson & Johnson
20Aug
Country Payroll Lead
Johnson & Johnson

Perform tasks related to analysis, execution, and support of payroll
processing. Maintain the utmost confidentiality in dealing with employee
records and business information. Assist with the development and delivery of
payroll training. Assist supervisor/manager with organizing tasks.
Required to work independently and may assist in specialized assignments.
Ensure that deliverables meet or exceed individual objectives, adhere to
payroll goals, and align with service center strategies.





RESPONSIBILTIES:
   Read more










Payroll Processing





Perform
payroll transactions such as data entry, mass uploads,
reversals/replacements, and payroll processing jobs (e.g.,
gross to gross and gross to net). Review, analyze, and reconcile
payroll and other payroll related data according to established timelines,
standards, and procedures.


Handle
complex and/or sensitive payroll requests and issues.


Examine
and verify payroll related data for accuracy and consistency.


Oversee
and ensure Payroll deadlines are met and according to Payroll Operations
procedures


Ensure
all company, federal, state, local, and other applicable compliance
requirements are met. Ensure payroll is executed in accordance with
SOX controls at all times.


Prepare
Payroll calendars for all paygroups.


Prepare
and process manual off-cycle pay. Review, analyze and update salary data
and calculate retroactive salary data as required.


Create
reports of activities and findings to document results and review with the
supervisor/manager.


Analyze
financial data and provide input to the payroll supervisor/manager.


Document
and review payroll operations procedures. Contribute to the ongoing
development and maintenance of documentation (e.g., Standard
Operating Procedures, Work Instructions) to ensure complete, accurate, and
up-to-date depiction of processes. Partner with the supervisor/manager to
assure version control, retention, and inventory of associated
documentation.


Assist
the supervisor/manager with day-to-day task planning and special
projects.







Business Improvement & Alignment





Assure
understanding of broader Payroll strategies.


Review,
follow, and provide input to payroll team objectives.


Provide
ideas, solutions, and tools to increase the effectiveness and efficiency
of payroll processing.


Support
the development, reporting, and review of metrics to drive performance,
identify trends, and develop/implement process improvements,
escalating issues and proposed solutions as appropriate.


Assist
the supervisor/manager with capturing and responding to escalated issues,
policies, and procedures from government agencies, payroll functions,
and the operating companies.







Teamwork and Individual Development





Communicate
regularly with supervisor/manager, team members, and appropriate
stakeholders regarding task or project status and opportunities to improve
service levels or processes. Escalate issues as appropriate to ensure
quality service levels.


Participate
in and support departmental initiatives.


Seek
feedback, continuously learn, and take advantage of opportunities to
improve knowledge, skill, and experience. Monitor results to improve
effectiveness and efficiency.


Adhere
to company, department, and team standards of professionalism and
protocol. Assure that behavior complies with the J&J credo and
supports a positive work environment.







Qualifications




University/Bachelors
Degree or Equivalent, in Finance/Accounting or Business Administration.


Generally,
requires (5-7) years Payroll or Finance related experience, with several years
of strong people management responsibilities.


Previous
experience in Payroll required, preferably for a large multi-state company.
Experience in a shared service center environment preferred.


Demonstrate
a strong understanding of Payroll processes, procedures, controls, regulations,
and compliance requirements.


Significant
analytical and problem solving skills required.
Attention to detail a must.


Proficient
verbal and written communication skills in order to communicate with customers,
peers, and vendors.


A
sense of urgency in solving customer requests to ensure timely resolution and
an ability to work under pressure, multi-task, and meet deadlines.


Demonstrate
a high degree of confidentiality and sensitivity to compliance-related
matters.


Ability
to influence others, identify problems, and recommend a course of action.


Experience
working on payroll projects. Able to process complex information and identify
solutions that meet both internal and business partner requirements.


Demonstrate
ability to handle ambiguity and fluid situations, demonstrating a pragmatic
approach.


Proficient
interpersonal skills and the ability to successfully work with internal
stakeholders and colleagues to contribute ideas, identify opportunities, and
contribute to positive outcomes.


Knowledge
of standard business practices and professionalism in a customer service
environment are essential.


Ability
to excel in a team based environment, demonstrating customer service and teamwork.
Experience working through conflict to reach a successful resolution.


Demonstrate
ability to disseminate knowledge and techniques. Experience providing feedback
to help others understand the rationale of desired outcomes and standards.


Certified
Payroll Professional (CPP) or Fundamental Payroll Certification (FPC) desirable.


Experience
with an ERP system required (payroll modules of SAP preferred).


Experience
with payroll applications and service providers desirable.


Experience
with Microsoft tools and applications required.





Primary Location


Singapore-Singapore-Singapore


Organization


Johnson & Johnson Pte. Ltd. (8435)


Job Function


Payroll


Requisition ID


1805655808W

Covance
20Aug
Medical Technologist III - Histology
Covance

Utilize knowledge and experience with histology samples to maintain proper storage conditions and facilitate accessioning of blocks and slides (stained and unstained). Routine decalcification, processing, embedding, microtomy and re-embedding of human tissue specimens from patients enrolled in clinical trials. Perform Immunohistochemistry and FISH testing according to protocols and SOPs. Perform slide scanning as required and according to protocols.


Instruments/equipment: Thorough working knowledge,    Read more

able to provide troubleshooting, resolve complex instrument & equipment problems. Works with vendor where needed to resolve


Training: Coordinate timely development & completion of training materials & checklists


SOPs: Initiates revisions, writes new SOPs to reflect current processes that ensures compliance.


Instrument/assay validation: Coordinates with other resources to ensure timely completion and implementation. May be asked to research, validate and maintain procedures in area of responsibility.


Process Improvement: Analyze existing processes and create new approaches or ideas to improve. Works with internal/external dept. to ensure successful implementation of changes/improvements. May serve as SME.


Supports client audit process and responding to inquiries


Serves as expert in all facets of trained workstations in area of responsibility. Responds to problems or questions of department staff.


Bachelor’s degree in a bio-medical, physical or biological science from an accredited college or university and one year training and/or experience in the specialty in which testing is to be performed.


Individual must have 3 or more years of Covance Laboratory experience performing clinical laboratory testing or experience in performing clinical laboratory testing judged as equivalent



Note: To apply for this job, submit your application by clicking on the

Apply Now

button on this page

Covance
20Aug
Laboratory Supervisor, Histology
Covance

Supervises day to day activities in department - utilizing knowledge and experience with histology samples to maintain proper storage conditions and facilitate accession of blocks and slides. Routine decalcification, processing, embedding, microtomy, IHC, ISH, FISH of human tissue specimens from patients enrolled in clinical trials.


Monitors quality of services provided by employees under his/her supervision


Assigns    Read more

appropriately trained personnel and ensures sufficient resources available to complete the workload


Schedules and supervises all non-production activities and obligations in dept., such as validations, surveys, etc.


Provides support as required to the dept manager, including acting as manager, upon delegation, during absences.


Assures quality and timely performance of both production and non-production activities under supervision


Ensures regulatory compliance, and participates in client visits, audits, inquiries as necessary


Recruits, trains and contributes to retention efforts of employees


Conducts technical training & development of staff as needed


Evaluates the performance of employees


Perform other duties as required, including testing of patient samples in areas of competence.


Bachelor’s degree in a bio-medical, physical or biological science from an accredited college or university and one year training and/or experience in the specialty in which testing is to be performed.


Requires 6 years of experience in a laboratory following clinical training; prior supervisory or management experience is a plus



Note: To apply for this job, submit your application by clicking on the

Apply Now

button on this page

GlaxoSmithKline
20Aug
Operational Quality Lead
GlaxoSmithKline

Your Responsibilities:

GlaxoSmithKline (GSK) is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have three global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies.
   Read more


We are proud of the difference we make. GSK has ranked 1st in the Access to Medicines Index all five times since its launch in 2008 and FORTUNE Magazine ranked us #1 on its ‘Change the World list’ which recognizes companies that have made significant progress in sustainable, scalable approaches to addressing societal problems as part of their company strategy.



Key Responsibilities:



To plan, co-ordinate, lead and manage the activities of the Operational Quality Section within the Value Stream 4, to ensure that all the relevant process raw materials, intermediates and final products are manufactured, tested and released in full compliance with cGMP and regulatory requirements that meet the defined quality standards.


To operate within the framework of safety, occupational hygiene, responsible environmental protection and in cognizance of the dynamic business environment.


Ensure that all attributes / elements contributing to product release decisions have been fulfilled promptly in accordance with requirements.


Ensure shift-based oversight of facilities, equipment and personnel to ensure real-time compliance to procedures, instructions, data integrity (ALCOA+) and other cGMP requirements. This includes participation in Rapid Response approach to address deviations, with Operations, Engineering and Technical.


Review, evaluate and approve changes that have / could have an impact on product quality, these include changes to product specification, method of analysis, process, plant, raw material supply etc.


Lead or participate in investigations arising from customer complaints, returned goods or product failure etc., and accurately assess the impact of the complaints / failure so as to make appropriate recommendations on remedial actions for follow-up.


Application Process

At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.


At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

If you would like to join us in innovating and inspiring changes in the industry, we urge you to apply.


Closing date for applications: Sept 15 , 2018



Why You?




Basic qualifications:



At least a degree in Chemistry, Engineering, Pharmacy or any relevant Science disciplines


At least 8 years in the quality assurance area in the pharmaceutical industry.



LI-GSK


Preferred qualifications:



Very good knowledge of GMP


Sound knowledge and on-going awareness of regulatory requirements (includes safety)


Good knowledge of manufacturing processes of Value Stream


Good communication skills


Basic financial management skills


Knowledge of business process within GSK


People management skills



Risk management skills



Why GSK?

:




GSK has been present in Asia for over 50 years and our commitment to the region is strengthened by the establishment of our purpose-built headquarters for Asia. Situated in Singapore, GSK Asia House is a further step in our long-standing strategy to grow and diversify our company - emphasizing the globally balanced business we have built over the years.


To better support Asia, we focus on developing talent to improve our ability to make the right decisions for healthcare professionals, patients and consumers across the region.


Contact information:

You may apply for this position online by selecting the Apply now button.


Important notice to Employment businesses/ Agencies


GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

GlaxoSmithKline
20Aug
Senior QA Validation Specialist
GlaxoSmithKline

Your Responsibilities:


Purpose:



To lead and manage Site validation activities, as assigned, to ensure that validations are in compliance with company procedures & regulatory requirements and cGMP expectations


To provide QA compliance oversight over IT and Technical Services; as assigned.
   Read more



Author and maintain the quality system SOPs for validation Define validation approach that is technically sound and are compliant


Author Validation Plans and Reports, including Continuous Validation Plan .


Review and approve validation deliverables.


Provide solutions to achieving validation requirements.


Collaborate with Operations to define the validation schedule and support the timely completion of activities as per schedule.


Drive efficiency, improvement and robustness in site validation systems


Be the link with Global Validation for technical information, and standards roll out.


Assess impact to validation and validation status during change management, and define appropriate validation requirements and approach to maintain validated status of systems.


Perform Annual Periodic Review and prepare the review report.


LI-GSK



Why You?




Basic qualifications:


At least University basic degree in a Science or Engineering discipline

At lease 2 years experience in pharmaceutical industry or related regulatory fields (at least 5 years for Snr QA Validation Specialist role)


Preferred qualifications:


A good understanding of cGMP regulatory and legal requirements as applied to quality assurance and validation of pharmaceutical manufacturing


Good understanding of regulatory inspection requirement


A good working knowledge of validation, preferably with hands-on experience


Computer skills in MS Office and familiar with web-based e-learning resources


Potential or developing project management skills



Why GSK?

:


GlaxoSmithKline (GSK) is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have three global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies.

We are proud of the difference we make. GSK has ranked 1st in the Access to Medicines Index all five times since its launch in 2008 and FORTUNE Magazine ranked us #1 on its ‘Change the World list’ which recognises companies that have made significant progress in sustainable, scalable approaches to addressing societal problems as part of their company strategy.

GSK has been present in Asia for over 50 years and our commitment to the region is strengthened by the establishment of our purpose-built headquarters for Asia. Situated in Singapore, GSK Asia House is a further step in our long-standing strategy to grow and diversify our company - emphasizing the globally balanced business we have built over the years. To better support Asia, we focus on developing talent to improve our ability to make the right decisions for healthcare professionals, patients and consumers across the region.


Contact information:

You may apply for this position online by selecting the Apply now button.


Important notice to Employment businesses/ Agencies


GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Covance
20Aug
Medical Technologist - Safety Testing
Covance

Grow your career with a global organization



Do you have knowledge in safety testung? Are you looking to extend your experience as a medical technologist in a dynamic, team-focused environment?


If you are looking for a growth opportunity within a supportive team, consider working at Covance as a Medical Technologist.


We are looking for talented

   Read more

Medical Technologist

for our

Safety Testing

section in Covance Central Laboratory Services Singapore. If you are already working in the biomedical industry in the capacity of Medical Technologist, this would be a great opportunity to develop your career.



Covance

is committed to providing a clinical research career with purpose in a culture that values achievement. By joining us, you will be working in one of the world’s best laboratory services, with access to the most advanced and comprehensive lab equipment and facilities. Medical Technologist with Covance will perform analysis and tests patients’ specimens to the highest level of accuracy. If this sounds like the role for you, reach out to us for a discussion!



About the Job:




Medical Technologist

performs and interprets non-invasive examinations of patients’ diseases in order to provide an analytical result for clinical trial management as well as an evaluation of the extent of the disease to plan the appropriate treatment and management. Responsibilities include:


Perform assigned clinical laboratory testing accurately and in a timely manner.


Properly handle specimens and independently resolve technical specimen issues in preparation for analysis and specimen storage, including resolution of pendings.


Operate instruments to perform testing in accordance with established written procedures.


Ensure the validity of tests results through the performance of established quality assurance and quality control procedures.


Perform accurate inventory records of consumables and reagents.


Complete testing within the expected turnaround time to meet customers’ expectations.


Ensures maintenance of instruments and equipment is performed according to manufacturer and SOP requirements, and documented according to SOP.


Comply with regulatory guidelines and Standard Operating Procedures (SOPs) at all times.



Build your skills at Covance



Benefit from our experience generating more clinical trial data than any other central laboratory in the world. You’ll gain exposure to our cutting-edge automated testing systems and advanced technologies while conducting tests that help advance life-changing medicines.



What we are looking for:



Bachelor’s degree in biological sciences/biomedical sciences/medical Technology preferred from an accredited college or university.


At least 2 year previous laboratory experience performing clinical laboratory testing or experience in performing clinical laboratory testing judged as equivalent.


Candidate with more experience will be considered for a more senior role accordingly.



Why Work with Covance:



Energizing Purpose


Exceptional People


Extraordinary Potential


We are focused on a workplace unlike any other; a place where you can build a rewarding career with talented colleagues while positively improving health and improving lives acrooss the globe.



Get to know Covance



We are focused on a workplace unlike any other; a place where you can build a rewarding career with talented colleagues while positively improving health and improving lives acrooss the globe.


Covance, the drug development business of LabCorp, is the world’s most comprehensive drug development services company. Because of our broad experience, from early research to commercialization, our more than 20,000 employees from across the globe are in a unique position to supply insights that go above and beyond testing. Our team’s impact on healthcare is remarkable. Through their everyday work they’ve supported 100% of the top 50 drugs on the market and all the oncology drugs approved in 2016. Even though we span multiple businesses, we operate as one, sharing our knowledge to improve our efficiency and deliver on the promise of a healthier world.


Bringing new medicines to market requires bold ideas. That’s why we empower our exceptional people with mentoring, in-depth training and tailored career planning. You’ll have the opportunity to own your career journey and develop alongside supportive, industry leaders who are passionate about your individual success. At Covance, you’ll discover your own extraordinary potential as you explore diverse projects and unique career paths across the drug development spectrum.


Join us and discover your energized purpose as we transform possibilities into reality for our clients—and your career.


Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.


Bachelor’s degree in biological sciences/biomedical sciences/medical Technology preferred from an accredited college or university.




At least 2 year previous laboratory experience performing clinical laboratory testing or experience in performing clinical laboratory testing judged as equivalent.


Candidate with more experience will be considered for a more senior role accordingly.



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Covance
20Aug
Medical Technologist I - Histology
Covance

♦ Utilize knowledge and experience with histology samples to maintain proper storage conditions and facilitate accessioning of blocks and slides (stained and unstained). Routine decalcification, processing, embedding, microtomy and re-embedding of human tissue specimens from patients enrolled in clinical trials. Perform Immunohistochemistry and FISH testing according to protocols and SOPs. Perform slide scanning as required and according to protocols.


♦Perform assigned clinical laboratory    Read more

testing accurately and in a timely manner, in accordance with established written procedures. Resolves routine and non-routine assay problems.


♦ Ensure the validity of tests results through the performance of established quality assurance and quality control procedures. Evaluation of new calibrator and/or QC lots, summarize investigations for review by management, documetnation of QC results, analyze proficiency testing survey samples as patient specimens.


♦ Reagents/Materials/Supplies: Receive, open and place in service all reagents/materials according to SOPs. Perform inventory control of supplies and reagents as approved by management.


♦ Result Entry (Auto-verification and manual entry). When data is manually entered (e.g. QC, patient data) ensure peer review is performed and documented prior to release of results. Prepare proper documentation of test results and enter into the information system. Generate an appropriate audit trail for all activities. Document and communicate any result reporting problems or inconsistencies to laboratory management. Complete testing within the expected turnaround time to meet customers’ expectations.


♦ Ensures maintenance of instruments and equipment is performed according to manufacturer and SOP requirements, and documented according to SOP. Perform basic instrument and equipment troubleshooting.


♦ Comply with regulatory guidelines and Covance Standard Operating Procedures (SOPs) at all times.


♦ Training: Individual is responsible for maintaining his/her complete up-to-date training file and is accountable for correcting and deficiencies found in his/her training file. Individual is responsible for ensuring he/she is trained and training is documented prior to performing a task. The individual successfully completes, as scheduled, competency assessment and ensures competency testing documentation is provided to management for review/retention. Competently performs department duties as set forth in the department training checklist(s). Attends, as scheduled, department, mandatory and other meetings and training, as required according to training matrices.


♦ Work to achieve partnership with both internal customers and external clients by: Pull data in a timely manner for review by QA and external clients. Contribute to the provision of accurate verbal or written response to internal QA and client audit findings. Coordinate, where needed, with other resources to resolve issue. Researches and prepares a response following investigation for quality purposes. Coordinate, where needed, with other resources to resolve issue.


♦ Adheres to established Safety policies and Universal precaution guidelines at all times. Maintains a clean, organized and safe work environment. Minimizes biohazard waste. Cleans workstation and materials daily.


♦ Takes action for the department when additional responsibilities and opportunities are presented.


♦ Other duties as assigned.


Bachelor’s degree in biological sciences/biomedical sciences/Medical Technology preferred from an accredited college or university.


at least 1 year previous experience in histology laboratory



Note: To apply for this job, submit your application by clicking on the

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